Table 7

Phase 3 CLL cladribine studies: untreated patients

Study/regimenNo. of patientsCladribine doseResponse, %
Median duration, moOS, mo
ORCR
Robak et al (2000)86        
    2-CdA + P 126 87 47 24 (P = .01): 46% 24 (P = .6): 78% 
    Chl + P 103 12 mg/m2/d PO + 30 mg/m2/d PO for 7 days 57 12 24 (33%) 24: 82% 
Robak et al (2006)87        
    2-CdA 166 77 21 24 (P = .47) 51 (P = .73) 
    2-CdA + Cy 162 83 29 22 (P = .49) Not yet reached 
    2-CdA + Cy + M 151 80 36 24 Not yet reached 
Karlsson et al (2007)85        
    2-CdA 72 75 NA 25 (P < .001) 82 (NS) 
    F 73 25 mg/m2/d IV for 5 days 70 NA 10 68 
    Chl 76 10 mg/m2/d PO for 10 days 62 NA 62 
Robak et al (2010)88        
    2-CdA + Cy 212 88 47 28 (P = .51) 48 (P = .16): 62% 
    F + Cy 211 25 mg/m2/d IV + 250 mg/m2/d IV for 3 days 82 46 27 48: 61% 
Study/regimenNo. of patientsCladribine doseResponse, %
Median duration, moOS, mo
ORCR
Robak et al (2000)86        
    2-CdA + P 126 87 47 24 (P = .01): 46% 24 (P = .6): 78% 
    Chl + P 103 12 mg/m2/d PO + 30 mg/m2/d PO for 7 days 57 12 24 (33%) 24: 82% 
Robak et al (2006)87        
    2-CdA 166 77 21 24 (P = .47) 51 (P = .73) 
    2-CdA + Cy 162 83 29 22 (P = .49) Not yet reached 
    2-CdA + Cy + M 151 80 36 24 Not yet reached 
Karlsson et al (2007)85        
    2-CdA 72 75 NA 25 (P < .001) 82 (NS) 
    F 73 25 mg/m2/d IV for 5 days 70 NA 10 68 
    Chl 76 10 mg/m2/d PO for 10 days 62 NA 62 
Robak et al (2010)88        
    2-CdA + Cy 212 88 47 28 (P = .51) 48 (P = .16): 62% 
    F + Cy 211 25 mg/m2/d IV + 250 mg/m2/d IV for 3 days 82 46 27 48: 61% 

2-CdA indicates cladribine; P, prednisone; Chl, chlorambucil; Cy, cyclophosphamide; M, mitoxantrone; F, fludarabine; IV, intravenously; PO, by mouth; and NS, not significant.

A indicates 0.12 mg/kg per day 2-hour intravenous infusion for 5 consecutive days + prednisone 30 mg/m2 PO for 5 days; B, 0.12 mg/kg per day as 2-hour intravenous infusion for 5 consecutive days; C, 0.12 mg/kg per day as 2-hour intravenous infusion for 3 consecutive days + cyclophosphamide 650 mg/m2 intravenous on day 1; D, 0.12 mg/kg per day as 2-hour intravenous infusion for 3 consecutive days + cyclophosphamide 650 mg/m2 intravenous on day 1 + mitoxantrone 10 mg/m2 intravenous on day 1; E, 5 mg/m2 2-hour intravenous infusion for 5 consecutive days; and F, 0.12 mg/kg per day as 2-hour intravenous infusion for 3 consecutive days + cyclophosphamide 250 mg/m2 per day intravenous for 3 consecutive days.

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